By /Published On: September 8, 2021/2.8 min read/

Introduction

The World Health Organisation (WHO) recommends an exclusive breast milk diet for all infants up to 6 months of age, and where mothers own milk is not available, donor milk should be used. Very low birth weight infants who fail to gain weight despite adequate breastfeeding should be given human milk fortifiers, preferably those which are human milk based. In the following article we explore the barriers faced by medical professionals of implementing these recommendations.

Variability of Human Milk

Human milk is highly variable. The composition of human milk varies both from mother to mother, but also throughout the different breastfeeding stages. As mature milk comes in at around 10-15 days after birth, it is highly likely that the majority of milk received in milk banks is mature milk, which is higher in volume with increased fat and lactose content and decreased protein and probiotics1.

A recent paper published in 2019 by British Journal of Nutrition2supported this. It calculated the mean values of protein, fat, carbohydrate and energy content of donor milk from a regional human milk bank and found the following.

Macronutrients Mean values per 100ml ESPGHAN Guidelines (/kg/day)
Protein 0.89g (SD 0.24) 3.5-4.5g
Fat 2.99g (SD 0.96) 4.8-6.6g
Carbohydrate 7.09g (SD 0.44) 11.6-13.2g
Energy 60.37kcal (SD 8.41) 110-135g

The variability of donor milk means that it is not always possible to achieve the ESPGHAN guidelines, or even to establish what nutrition a baby is receiving, and preterm and low birth weight babies will be at particular risk from this. 

In total 200 unique human milk oligosaccharides (HMO) structures varying from 3-22 sugars have been identified in mothers milk, however a study carried out in 2008 at the University of California Department of Nutrition, found that milk from randomly selected mothers contained as few as 23, and as many as 130 different oligosaccharides3. This means that whether or not a baby gets the full benefit of a 100% EBM diet from donor milk can be down to luck.

Increasing the number of donors in donor human milk pools may help optimise bioactive components in donor human milk received by premature infants4. Pooling milk allows products to be standardised, ensuring the same level of nutrition, and greater diversity of HMO’s across different batches at different times. 

Current NICE Guidelines

The NICE CG935 published in 2010 provides a framework for the operating service of milk banks in the UK, and does not recommend the pooling of donor breast milk. Although they accepted that there were many studies supporting the pooling of donor milk and the benefits were highlighted, the primary reason for the recommendation was the theoretical, unknown risk of CJD transmission. 

New research however, indicates that the transmission of CJD through mothers’ milk is extremely low. The CJD Support Network of the UK states “The risk of transmission of disease, as an infection, from a mother affected by CJD to a child in the womb, during delivery or via breast-feeding, appears to be extremely low, if it is a risk at all. It is, on the basis of present knowledge, just a theoretical risk with no reported instance of this in humans6.”

Human Milk Products in Use

Human milk products to support the feeding of preterm babies have been available in the US for the last 15 years7. 40% of all level 3 and 4 NICUs in the United States have come to rely on human milk-based neonatal nutritional products to feed the most fragile premature infants in their care.

The clinical research has demonstrated

  •  Reduced probability of NEC and Sepsis8
  • Decreased number of days in hospital9
  • Reduced duration of parenteral nutrition10
  • Reduced rate of BPD and ROP8

Milk pooling is currently allowed by the Human Milk Banking Association of North America and Rede Brasileira de Bancos de Leite Humano11 in Brazil which has the world’s highest number of milk banks. The most common practice is to pool milk from multiple donors in order to ensure an even distribution of nutrients such as protein and fat12 and increase the diversity of micronutrients.

NeoKare 100% Human Milk-Based Products

NeoKare Nutrition manufactures 100% human milk-based products in the UK and has a robust 5 step manufacturing process. Our safety and consistency framework follows through from milk expression to NICU.

Onboarding of Milk providers

Consistent with NICE CG93 recommendations5, each milk provider completes a screening questionnaire, consent form and conducts serological testing (HIV1&2, HBV, HCV, HTLV, syphilis) before donations can be made.

Hazard Analysis & Critical Control Point (HACCP) Plan

Our site consists of multiple ISO-7 cleanrooms and an onsite chemical and microbial testing laboratory

Traceability

Our tracing system provides batch process records from the provider to the finished product. Inspected by Worcestershire Regulatory Services (WRS) in May 2020, our facility was recognised for the “implementation of high levels of food safety compliance”, and following a further food safety inspection on 13th June 2021, our manufacturing premises were awarded the highest food hygiene rating of FHRS L5.

Testing

Every cooler received from each individual milk provider is chemically & microbiologically tested in our onsite laboratory before processing. Pre-production & in-line testing is completed on all donor milk both pre and post pooling, finally finished product is tested both in site and by a 3rd party UKAS accredited laboratory.

Conclusion

In conclusion, evidence shows that the benefits of pooling milk far outstrip the potential risks. Evidence gathered and technological advances since the NICE CG93 guidelines were written call for a review and revision of the UK NICE recommendations.

References:

  • Coppa et al. (1993) Pediatrica;91:637−41
  • Mills L, Coulter L, Savage E, Modi N. Macronutrient content of donor milk from a regional human milk bank: variation with donor mother-infant characteristics. Br J Nutr. 2019 Nov 28;122(10):1155-1167. 
  • Human Milk Oligosaccharides: Evolution, Structures and Bioselectivity as Substrates for Intestinal Bacteria J. Bruce German, Samara L. Freeman, Carlito B. Lebrilla, David A. Mills Department of Nutrition, University of California, Davis, CA, USA 
  • Young BE, Murphy K, Borman LL, Heinrich R and Krebs NF (2020) Milk Bank Pooling Practices Impact Concentrations and Variability of Bioactive Components of Donor Human Milk. Front. Nutr. 7:579115. doi: 10.3389/fnut.2020.579115 
  • NICE Clinical Guideline CG93 Donor Milk banks: Service operation, February 204
  • https://www.cjdsupport.net/what-is-cjd/frequent-questions 
  • Prolacta press release 
  • Hair AB, Peluso AM, Hawthorne KM, et al. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134 
  • Costs of Necrotizing Enterocolitis and Cost-Effectiveness of Exclusively Human Milk-Based Products in Feeding Extremely Premature Infants, Breastfeeding Medicine, Volume 6, Number 0, 2011, DOI: 10.1089/bfm.2011.0002 
  • Cristofalo EA, Schanler RJ, Blanco CL, et al. J Pediatr. 2013;163(6):1592-1595.e1. doi:10.1016/j.jpeds.2013.07.011   
  • PATH. Strengthening Human Milk Banking: A Global Implementation Framework. Version 1.1. Seattle, Washington, USA: Bill & Melinda Gates Foundation Grand Challenges initiative, PATH; 2013. 
  • Human Milk: Lessons from Recent Research, Ann Nutr Metab 2016;69(suppl 2):8–15, DOI: 10.1159/000452821

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